F&P Airvo 3— 510(k) K221338

Name: FDA 510(k) clearance K221338
Creator: U.S. Food and Drug Administration
Published: 2023-01-27

Substantially Equivalent

Fisher & Paykel Healthcare

FDA 510(k) clearance K221338 for F&P Airvo 3, Substantially Equivalent on 2023-01-27. Applicant: Fisher & Paykel Healthcare. Device class: 2.

Clearance details

Applicant: Fisher & Paykel Healthcare
Product code: Code QAV
Device class: Class 2
Regulation: 21 CFR 868.5454
Advisory panel: Anesthesiology
Date received: 2022-05-09
Decision date: 2023-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manukau, NZ

Download summary PDF View on FDA.gov ↗

Recent devices under product code QAV

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K221318 — HVT 2.02022-12-13
DEN170001 — Precision Flow® HVNI2018-04-10

More clearances from Fisher & Paykel Healthcare

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K222292 — F&P myAirvo 32024-05-08
K220703 — F&P 950 Respiratory Humidifier2023-06-16
K162553 — AirSpiral Heated Breathing Tube2018-12-20
K162582 — HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit2017-06-23

Adverse events under product code QAV

product code QAV

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K221338

K-number listed on FDA's recall record

Z-3262-2024 — PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities.Class II·Ongoing·Fisher & Paykel Healthcare, Ltd.·20240807

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K221338.

Data sourced from openFDA. This site is unofficial and independent of the FDA.